Carcinoma, Non-Small-Cell LungPhase 2NCT00266877
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing HKI-272 in people with Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by Puma Biotechnology, Inc. at 19 sites in 5 countries.
Trial summary
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
- What is being tested?
- HKI-272
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Dec 2005to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
- Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
- Tumor sample available and adequate for analysis.
- At least one measurable target lesion.
- Adequate cardiac, kidney, and liver function
- Adequate blood counts
Who cannot join
- More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
- Significant cardiac disease or dysfunction.
- Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
- Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
- Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
- Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer therapy within 3 weeks of treatment day 1.
Show all 9Show fewer
- Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- Inability or unwillingness to swallow HKI-272 capsules.
- Pregnant or breastfeeding women.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States11 sites
Massachusetts General Hospital, Yawkey Center for Outpatient Care
Boston, Massachusetts, 02114
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, 28203
Case Western Reserve University
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6868
Memorial Sloan-Kettering
New York, New York, 10021
Swedish Cancer Institute
Seattle, Washington, 98104
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Midwestern Regional Medical Center
Zion, Illinois, 60099
Poland4 sites
Akademia Medyczna W Gdansku
Gdansk, 80-952
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Otwock, 05-400
Wielkopolskie Centrum Chorób Płuc i Gruźlicy
Poznan, 60-569
Dolnośląskie Centrum Chorób Płuc we Wrocławiu
Wroclaw, 54-439
Hungary2 sites
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, H-1529
University of Debrecen
Debrecen, H-4012
About this study
Official title: A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
- Being tested
- HKI-272
- Keywords
- Lung Cancer, HKI-272, Neratinib, Nerlynx
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HKI-272Drug
Also called Neratinib
320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Prior Tarceva or Iressa With EGFR Mutation | Experimental | HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening Receives: Drug: HKI-272 |
| Prior Tarceva or Iressa w/o EGFR Mutation | Experimental | HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening Receives: Drug: HKI-272 |
| No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Experimental | HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) Receives: Drug: HKI-272 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Measured: From first dose date to progression/death or last tumor assessment, up to three years.
Secondary outcomes (3)
Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From first dose date to progression/death or last tumor assessment, up to three years.
Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Measured: From start date of response to first PD, assessed up to three years after the first randomization.
Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From first dose date to progression/death, assessed up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Puma, Study director, Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266877
- Sponsor's protocol ID
- 3144A1-200
- Other IDs
- B1891037
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2005
- Last updated
- 13 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00266877
- Acronym / sponsor ID
- 3144A1-200
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
- Keywords
- Lung Cancer, HKI-272, Neratinib, Nerlynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Puma Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Posted 13 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prior Tarceva or Iressa With EGFR Mutation | Experimental | Drug: HKI-272HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening |
| Prior Tarceva or Iressa w/o EGFR Mutation | Experimental | Drug: HKI-272HKI-272 administered to patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening |
| No Prior EGFR Tyrosine Kinase Inhibitor Treatment | Experimental | Drug: HKI-272HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV, not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years smoking history and current non smoker. A pack year = number of packs of cigarettes smoked per day x years smoked.
- Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A and B only)
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not declining within past 2 weeks).
- Tumor sample available and adequate for analysis.
- At least one measurable target lesion.
Key exclusion criteria (9 listed)
- More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic disease.
- Significant cardiac disease or dysfunction.
- Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.
- Active central nervous system metastases, as indicated by clinical symptoms and/or progressive growth.
- Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HKI-272Also: Neratinib320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability. | Drug | No Prior EGFR Tyrosine Kinase Inhibitor Treatment, Prior Tarceva or Iressa With EGFR Mutation, Prior Tarceva or Iressa w/o EGFR Mutation |
Primary outcome
Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Time frame: From first dose date to progression/death or last tumor assessment, up to three years.
Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
3 secondary outcomes
Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Time frame: From first dose date to progression/death or last tumor assessment, up to three years.
Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer
Time frame: From start date of response to first PD, assessed up to three years after the first randomization.
Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer
Time frame: From first dose date to progression/death, assessed up to three years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puma study director
Biotechnology
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HKI-272 in people with Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by Puma Biotechnology, Inc. at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Poland, Hungary, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer (time frame: From first dose date to progression/death or last tumor assessment, up to three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.